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NCT03165994 · ClinicalTrials.gov registry record · Phase 2
APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers
A Phase 2 study, sponsored by Apexigen America.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT03165994 is a Phase 2 study that has completed, run by Apexigen America. The registered enrollment target is 34 participants.
The verdict
NCT03165994, a Phase 2 study, has completed, sponsored by Apexigen America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
This pilot phase II trial studies the therapeutic effects and side effects of CD40 agonistic monoclonal antibody APX005M when combined with chemotherapy and radiation therapy, and to see how well they work to reduce or remove esophageal or gastroesophageal (GE) cancers when given before surgery in treating patients with esophageal cancer or GE cancer than can be removed by surgery. APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving APX005M, chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Radiation Therapy
- DRUG APX005M
- PROCEDURE Surgical resection of tumor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-10-06 |
| Est. Completion | 2023-02-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03165994
The ClinicalTrials.gov registry entry for NCT03165994 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Apexigen America, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT03165994 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03165994 about?
NCT03165994 is a clinical study titled "APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers". This pilot phase II trial studies the therapeutic effects and side effects of CD40 agonistic monoclonal antibody APX005M when combined with chemotherapy and radiation therapy, and to see how well they work to reduce or remove esophageal or gastroesophageal (GE) cancers when given before surgery in t...
What is the current status of trial NCT03165994?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2017-10-06. Estimated completion is 2023-02-21.
What interventions are being tested in trial NCT03165994?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Radiation Therapy (RADIATION), APX005M (DRUG), Surgical resection of tumor (PROCEDURE).
Who is sponsoring clinical trial NCT03165994?
This trial is sponsored by Apexigen America, which has 3 total clinical trials registered on ClinicalTrials.gov.
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